Kornimate/medical-research-clean huggingface dataset:
closed eye neutrophils in dry eye disease

Conditions: Dry Eye; Ocular Inflammation

Summary: the purpose of this prospective study is to evaluate different inflammatory cells that accumulate on the ocular surface, during sleep, and how these cells may contribute to dry eye disease. this study will involve at-home self-collection of tears using an eye wash method with sterile saline solution. while a diagnostic technique, the eye wash may also have a therapeutic benefit in dry eye sufferers, which will be assessed in the second phase of this project.

every night during sleep, there is an influx of white blood cells on to the surface of the eye. these cells likely perform a protective function, but it is also possible that their dysregulation could lead to disease. using a larger cohort, our investigation hopes to better understand the function of these cells and their potential to be linked to dry eye disease. further, the way in which these cells are collected, using an at-home self-collection of tears using an eye wash method with sterile saline solution, immediately upon awakening, could potentially provide relief to dry eye sufferers if performed on a daily basis.

Eligibility criteria:
inclusion criteria: * able to understand and sign an informed consent and hipaa privacy document * greater than 18 years of age at time of informed consent * able and willing to follow protocol instructions, including performing at-home washes of the ocular surface and subsequent delivery of those samples to campus on a regular basis * must be willing to have blood drawn exclusion criteria: * contact lens wear within past three months * current consumption of cigarettes or tobacco, including e-cigarettes * participation in any investigational drug studies within 30 days of informed consent * pregnancy, by self-report * active ocular infection or inflammation * any refractive surgery within the past year * any present accutane (isotretinoin) use * any medication usage that, in the investigator's opinion, could be expected to interfere with the study, such as current use of topical steroids, restasis, or xiidra * have any uncontrolled systemic disease, that in the investigator's opinion could be expected to interfere with the study, for example, conditions associated with dry eye disease

Keywords: dry eye disease tears inflammation ocular surface
immunogenicity and safety of quadrivalent influenza vaccine (nbp607-qiv) in adults and elderly subjects

Conditions: Influenza

Summary: all participants received a single dose of their assigned vaccine on day 0. they were followed up for immunogenicity and safety through day 21 post-vaccination. serious adverse events were collected for 6 months post-vaccination.

in a randomized controlled phase iii trial undertaken in 10 university hospitals of south korea, adults and elderly subjects were randomly assigned in a 2:1:1 ratio to nbp607-qiv versus cell culture-based trivalent inactivated influenza vaccine (tiv), nbp607-y and nbp607-v. immunogenicity was assessed 3 weeks after vaccination by hemagglutination inhibition (hi) assay. safety was assessed for 6 months post-vaccination: solicited adverse events for 7 days, unsolicited adverse events (aes) for 21 days and serious adverse events (sae) for 6 months.

Eligibility criteria:
inclusion criteria: * adults aged 19 years and older * those who are able to comply with the requirements for the study * if women, a negative pregnancy test and willingness to use birth control measures for the entire study duration exclusion criteria: * disorders in immune function * any malignancy or lymphoproliferative disorder * history of guillain-barré syndrome * individuals with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time * experience of fever (\>38.0 ℃) within 24 hours following vaccination * body temperature \>38.0 ℃ at the vaccination day * concomitant medications/therapy such as immunosuppressants or immune modifying drugs, systemic corticosteroids, immunoglobulins, blood or blood- derived products within 3 months * influenza vaccination within 6 months * subjects who have participated in other interventional study within 4 weeks * any vaccination within 1 month * those who are planning to receive any vaccine within 1 month from the study vaccine * individuals with any serious chronic or progressive disease * pregnant or breast-feeding women * any other reason that in the opinion of the investigator might interfere with the study

Keywords: influenza vaccine quadrivalent inactivated cell culture-derived
exercise-based rehabilitation to treat persistent chemotherapy induced peripheral neuropathy (cipn)

Conditions: Chemotherapy-induced Peripheral Neuropathy

Summary: the goal of this clinical trial is to learn if the ex-cipn exercise-based intervention is feasible, acceptable, and safe in participants with persistent chemotherapy-induced peripheral neuropathy (cipn). it will also give insight on the effectiveness of the exercise intervention in treating cipn symptoms. the main questions it aims to answer are: * is ex-cipn safe, acceptable, and feasible in cancer survivors experiencing persistent cipn? * are the study design and methods feasible (recruitment and retention rates, feasibility of data collection and procedures)? researchers will provide all participants with the exercise-based intervention. participants will: * complete assessments at baseline, immediately post-intervention, and 3-months post-intervention * complete a 10-week remote, individualized exercise program * receive health coaching calls on weeks 2, 3, 4, 6, and 8 of the intervention * wear a fitbit throughout the study to track physical activity and promote behaviour change


Eligibility criteria:
inclusion criteria: * received a diagnosis of any cancer and treated with curative intent (no minimum dose) including stage 3 \& 4 gynecologic malignancies, treated in the platinum-sensitive setting * are \> 6 months post-completion of chemotherapy (ie no other chemotherapeutic agents since completing of the chemotherapy regimen) * report \> grade 1 on the patient reported nci common terminology criteria for adverse events version 5.0 grading scale (numbness and tingling severity item) and neuropathic pain \>3 on the neuropathic pain 4 (dn4) (interview) (0-7) * the presence of peripheral neuropathy due to chemotherapy (following onset of chemotherapy), as established via clinical assessment * may be on maintenance oncologic therapies (ie endocrine therapy, poly (adp-ribose) polymerase (parp) inhibitors) not known to cause neuropathy * no current plans for chemotherapy in the next 6 months * currently engaging in \< 90min per week of planned moderate-intensity aerobic exercise * independent with ambulation and transfers with or without ambulatory assistance (egog 0-2) * able to communicate sufficiently in english to complete intervention, questionnaires, and consent * willing to participate in the intervention and attend in-person physical assessments * have access to and are able to operate videoconferencing. exclusion criteria: * known neurological conditions influencing cognition and preventing safe or appropriate engagement with self-management and exercise recommendations * pre-existing neuropathy prior to the start of chemotherapy * are currently enrolled in other cancer rehabilitation or exercise-based programs/interventions. * are currently taking ado-trastuzumab emtansine (tdm1) (ex. kadcyla)

Keywords: cancer rehabilitation peripheral neuropathy
knee osteoarthritis care: a quality improvement intervention in general practice

Conditions: Knee Osteoarthritis

Summary: the aim of this study is to improve the referral rates to physiotherapy of patients with knee osteoarthritis. the intervention consists of one academic detailing visit directed to general practitioners (gps)

in belgium, referral rates to physiotherapy of patients with knee osteoarthritis are low. a surveys shows that only 11% of the patients with knee osteoarthritis are referred for physiotherapy in an early stage of the disease process. referral to physiotherapy is common after arthroplasty for revalidation, but not in early stage of the disease process. the aim of this study is to increase the referral rate for physiotherapy in an early stage of the disease process. one to three times a year, a large part of belgian gps receive an academic detailing visit by an independent medical visitors of farmaka. farmaka is a non-profit organization, which is sponsored by the government. each year, three medical and medication-related themes are developed to provide evidence-based and independent information for primary care management. a visit takes about 20 minutes. the medical visitors of farmaka will spend 5 minutes of their standard visit to inform gps about the evidence-based conservative management of knee osteoarthritis with physiotherapy. the information will focus on the referral of patients with knee osteoarthritis to a physiotherapist in an early stage of the disease. to optimize the effect of the referral to physiotherapists, gps are asked to specify their prescription by adding a clear therapy description 'exercise therapy with aerobic, muscle strengthening and functional exercises'. this information will be summarized on a flyer. this flyer will be distributed to the gps at the end of the academic detailing visit. the flyer gives more extended information about the approach and treatment of knee osteoarthritis. the information and flyer will only be distributed to the intervention group. for the sample size calculation we want to optimize the referral rate to physiotherapists with 15%. to detect an absolute difference of 15% in referral rate to physiotherapists we need 100 patients in each group ( with significance level of 5%, 1 on 1 allocation and power of 80%). the control group is composed of gps, visited by farmaka, who will not receive the additional information on knee osteoarthritis management. after 6 months the gps of the intervention and control group will receive two case vignettes on the management of knee osteoarthritis. the number of referrals to a physiotherapist of the intervention group and the control group will be compared, as well as the number of specified well-directed prescriptions.

Eligibility criteria:
inclusion criteria: * active gp setting * visited by independent medical visitors for academic detailing exclusion criteria: * not willing to participate * not visited by independent medical visitors for academic detailing

Keywords: intervention, improvement strategy
the prognostic impact of selenium on critical surgical patients

Conditions: Critical Illness; Selenium Deficiency; Trace Element Deficiency; Acute Abdomen; Sepsis

Summary: selenium is an important trace element for human for its multiple roles such as the antioxidant activity. previous evidences showed that critically ill patients may benefit from selenium supplement but the dose and results are controversial. patients after operations for acute abdomen usually suffer from sepsis and stress. the aim of this study is to investigate the efficacy of selenium replacement in critical patients of acute abdomen, to see the impact on prognosis.

acute abdomen is a common surgical emergency and is often the result of peritonitis due to an acute inflammatory process within abdominal cavity. many of the patients with acute abdomen have severe sepsis and are critically ill that require an emergency surgery. the mortality rate of such patients are high because these patients usually have a profound pathophysiological dysregulation and multiple organ dysfunction. one of the mechanism of is the loss of anti-oxidative capacity of cells that fail to recover from ischemic-reperfusion injury. selenium is an important cofactor that participate in the antioxidant activity of glutathione peroxidase reaction. there are evidences that critically ill patients may benefit from selenium supplement by better outcome and less mortality but the dose and results are still heterogenous and inconclusive. the aim of this study is to investigate the efficacy of selenium replacement in critical patients of acute abdomen, to see if there is a significant impact on prognosis, and to establish a clinical guide in the future.

Eligibility criteria:
inclusion criteria: * intensive care unit (icu) patients receiving abdominal surgeries for acute abdomen * within 48 hours post-operatively * stay in icu for more than 48 hours * meets sepsis criteria of sepsis-3 (2016) exclusion criteria: * liver cirrhosis child-pugh score b or c * breastfeeding or pregnancy * allergy yo selenium * vegetative status or irreversible diseases with life-expectancy fewer than 28 days * end-stage renal disease under dialysis * human immunodeficiency virus infection * neutropenia not due to sepsis (granulocyte \< 1000/mm3) * heart failure (new york heart association class iii-iv) or recent myocardial infarction (within 6 weeks) * post cardiopulmonary cerebral resuscitation within 4 weeks * taking immunosuppressants * receiving anti-cancer therapy * signed do not resuscitation * joined other clinical research
stem cell treatment of peyronie´s disease.

Conditions: Penile Induration; Penile Diseases

Summary: purpose of the project is to investigate if a single injection of autologous stromal vascular fraction into and around plaque is a safe and suitable treatment. twentythree men \> 18 years with peyronie´s disease in the chronic phase will be recruited. the operative same-day procedure will be performed in general anaesthesia by a plastic surgeon. before the patient wake, local anaesthesia is put around the penis. processed stem cells are injected into the plaque/fibrosis subcutaneously. there will be a follow up at 1, 3, 6, 12 months. it is a pilot study with no randomisation. the group will be compared to a historical control group.


Eligibility criteria:
inclusion criteria: 1. acquired penile curvature \>30 and \<90 degrees associated with a palpable penile plaque on physical examination. 2. one or several plaques at ultrasound screening. 3. willingness to attend follow-up at 1, 3, 6 and 12 months. 4. understand and speak danish. 5. men \> 18 years of age exclusion criteria: patients may not be: 1. taking the medication coumadin, warfarin or noak (new oral anticoagulant). 2. unable to achieve adequate erection with penile injection to access degree of curvature. 3. undergoing definitive treatment for prostate cancer, bladder cancer, or other pelvic malignancies including surgery, external beam radiation therapy, brachytherapy, and cryotherapy. 4. with prior history of prostate cancer, hematologic disorders, chronic liver disease including cirrhosis and hepatitis c, disorders affecting the immune system, including infection with the human immunodeficiency virus, or psychiatric disorders including but not limited to major depression, schizophrenia, bipolar disease. 5. with a history of cerebrovascular incidents, a history of deep venous thrombosis within the past 5 years or a history of untreated or severe sleep apnoea. 6. with a clinically significant abnormal, results that would put the subject at increased risk or compromise the integrity of the study data, in the opinion of the investigator. blood tests will be analysed for hiv, hepatitis b and c and syphilis and those applicable within guidelines of the department. 7. involved with any other projects with an investigational drug within 30 days. 8. in treatment for alcohol or drug abuse within six months. 9. with congenital deviation of penis. 10. within six months treated with collagenase, eswt and/or other therapeutic injection in the plaque treatment for pd.

Keywords: stromal vascular fraction peyronie´s disease peyronie´s disease questionnaire erectile dysfunction
the effect of continuous passive motion training on neuromuscular adaptation

Conditions: Spinal Cord Injury(SCI)

Summary: after spinal cord injury (sci), the muscular property altered due to the immobilization adaptation. the purpose of this study was to investigate the effect of remobilization with continuous passive exercise on the adapted paralyzed muscle properties after sci.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of chronic spinal cord injury

Keywords: spinal cord injury passive motion fatigue index hypertonia
family planning intentions and practices among women with poor obstetric outcome

Conditions: Stillbirth

Summary: women who have experienced a stillbirth or neonatal death are at higher risk of repeated poor neonatal outcomes if they have short interpregnancy intervals. understanding the attitudes surrounding future fertility and contraception in this population is critical to propose socially and culturally acceptable interventions to address an unmet need for family planning. participants: women who have experienced a stillbirth or early neonatal death will be recruited from the postnatal ward of bwaila maternity hospital in lilongwe, malawi. procedures (methods): this will be a qualitative study using 20 in-depth interviews and four focus group discussions of up to 10 women each.

the investigators propose a qualitative study of up to 60 women who have experienced a stillbirth or early neonatal death. this will be a qualitative study using 20 in-depth interviews and four focus group discussions of up to 10 women each. in-depth interviews will be conducted in chichewa in a private room either within the participants' homes or in another private location determined by the participant. each interview will take approximately 60-90 minutes to complete. the focus group discussions will be conducted in a private room in a health facility with 6-10 participants. these will take approximately 90-120 minutes to complete. interviews and the focus group discussion will be audio-recorded, transcribed, and translated to english. if a participant is found to be eligible, she will be invited to participate in the study. after the investigators complete the in-depth interviews, the investigators will analyze the data and modify our focus group discussion guide as needed to integrate new themes that may have emerged during the individual interviews. the investigators will recruit 6-10 women per focus group (24 to 40 total) from the same hospital that were used to recruit for the individual interviews. the investigators will search for recurrent patterns and themes in data and for ideas that help to explain the presence of these patterns. the data collection and analysis process is designed to be iterative, such that the investigators will be reviewing data as it is collected and adjusting the data collection instrument to reflect new themes that emerge during the data collection process. all interviews will be audio-recorded, transcribed, translated, coded and computerized for analysis.

Eligibility criteria:
inclusion criteria: 1. current admission to the postpartum ward at bwaila hospital, 2. women who have delivered a stillborn fetus over 28 weeks gestation or with a birthweight \>1000 g or experienced a neonatal demise of a liveborn infant, weighing \>1000 g in the first 7 days of life, 3. ability to speak chichewa or english fluently, and 4. age 18-45 years old. exclusion criteria: * not willing to be audio-recorded * have not experienced stillbirth or early neonatal death

Keywords: family planning birth spacing
study evaluating tmi-005 in active rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the primary objective of this clinical research study is to compare the efficacy and the safety of 3 dose levels of oral tmi-005 in comparison with placebo in subjects with active rheumatoid arthritis (ra) who have been receiving stable doses of methotrexate (mtx).


Eligibility criteria:
inclusion criteria: * meet american college of rheumatology (acr) criteria for ra * have active ra * disease duration of at least 6 months * disease onset at \> 16 years of age. exclusion criteria: * any prior use of anti-tnf alpha biologics, rituximab, receipt of anti-cd4 or diphtheria interleukin-2 fusion protein or other immunosuppressive biologics (except for anakinra) * largely or wholly incapacitated with the subject bedridden or confined to a wheelchair, permitting limited or no self-care * pregnant or breastfeeding women or women planning to become pregnant during the study or within 12 weeks after the last dose of test article
playing cognitive games for older adults with insomnia

Conditions: Insomnia

Summary: the purpose of this research is to look at the effects of computerized cognitive training on sleep, mental abilities (cognition), and other aspects of daytime functioning, such as mood, and arousal


Eligibility criteria:
inclusion criteria: * 60+ yrs of age. * no neurological or psychiatric illness, dementia, or loss of consciousness \> 5 mins. * nongamers (i.e. \<1 hour of video/cognitive training games per week over last 2 years) * proficient in english (reading and writing). * meet clinical diagnosis for insomnia. insomnia: * insomnia complaints for 6+ months. * complaints occur despite adequate opportunity and circumstances for sleep. * consist of 1+ of the following: difficulty falling asleep, staying asleep, or waking up too early * daytime dysfunction (mood, cognitive, social, occupational) due to insomnia. exclusion criteria:. * unable to provide informed consent. * unable to undergo randomization. * cognitive impairments (i.e. mild cognitive impairment, dementia) * other sleep disorder (i.e., sleep apnea, periodic limb movement disorder) * severe untreated psychiatric comorbidity that renders randomization unethical * using psychotropic or other medications (e.g., beta-blockers) that alter sleep * uncorrected visual/auditory impairments * participation in nonpharmacological treatment for sleep/fatigue/mood outside the current study.

Keywords: insomnia cognitive training sleep cognition polysomnography actigraphy older adults